- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05824624
The Effect Of Animal-Assisted Intervention
April 20, 2023 updated by: Mukaddes Demir Acar, Tokat Gaziosmanpasa University
The Effect Of Animal-Assisted Intervention On Fear In Hospıtalızed Children In The Emergency Department: A Randomized Controlled Study
The aim of the study is to examine the effect of animal-assisted practice on fear in children admitted to the emergency room.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Children's fears about the hospital are traumatic and confront us as a hindering factor in their growth and development.Bringing the child to the emergency room and not knowing what will happen there creates great fear in him.
Children already have different fears according to different age groups and developmental stages.
These; separation from family, pain and suffering, change in body image (losing body parts), etc.
The state of fear can lead to a worsening of the child's existing illness and symptoms.
In addition to being separated from the family, being separated from peers, not being able to play games, staying away from school if going to school, etc. they have concerns.
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mukaddes Demir Acar, DR
- Phone Number: +905055790222
- Email: mukaddesdemir.acar@gop.edu.tr
Study Contact Backup
- Name: Gülmelek Yılmaz, RN
- Phone Number: 5067340746
- Email: gulmelek.yilmaz@gop.edu.tr
Study Locations
-
-
Eyalet/Yerleşke
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Tokat, Eyalet/Yerleşke, Turkey, 60200
- Tokat Gaziosmanpaşa University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- To be followed for at least 2 hours in the pediatric emergency room,
- Age range is 5-7,
- Not afraid of the goldfish to be used in the research,
- Not allergic to fish and fish feed,
- Does not have physical, auditory, visual and cognitive barriers to feeding (feeding),
- No speech or communication disorder that will prevent the parent and child from communicating,
- Parent and child's willingness to participate in the research
Exclusion Criteria:
- Patients who are not admitted to the Pediatric Emergency room, patients who do not fit the age range of 5-7, who stay less than 2 hours,
- Afraid of goldfish, allergic to fish food, preventing feeding, having physical, auditory, visual and cognitive disabilities,
- Patients with speech and communication disorders that will prevent parents and children from communicating,
- Parent and child not willing to participate in the research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
Animal-supported application will be made to the children in the study group.
|
It will be ensured that the child is introduced to the goldfish when he is lying in the observation room, that the child will name the fish, and that he will communicate and feed the fish during his stay.
Thus, it is aimed to turn the attention of the child to the goldfish while in the emergency room, to distract the child with the fish while all nursing interventions are presented, and to reduce the fear.
|
|
Experimental: control group
Routine care will be given to the children in the control group.
|
Routine nursing care will be provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Scale Development of Fear in Children Against Nursing Interventions and Used Materıals
Time Frame: 2 hours
|
The scale was created to develop a valid and reliable measurement tool for children to determine their fear of nursing interventions and used materials.
As a result of the validity and reliability analyzes of the scale, it was composed of 18 items.
The scale has 2 sub-dimensions.
These are fear of common materials (10 items) and fear of uncommon materials (8 items).
The scale was scored as (1) not afraid, (2) little afraid, (3) afraid, (4) very afraid, (5) extremely afraid.
|
2 hours
|
|
Child Fear Scale
Time Frame: 2 hours
|
The Scale is a scale consisting of the display of five drawn facial expressions, ranging from neutral expression (0 points) to "no fear" to frightened face (4 points) to "severe fear".
The scale is intended for children aged 5-10 years.
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mukaddes Demir Acar, Tokat Gaziosmanpaşa University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Özalp Gerçeker, G., Ayar, D., Özdemir, Z., & Bektaş, M. 2018. Gaining of Children's State Anxiety and Children's Fear Scale to Turkish Language. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.
- Eren Kok H, Orsal O. The Development of a Scale to Measure Children's Fear of Nursing Interventions and Instruments Used in Hospital. Psychiatry and Behavioral Sciences 2023;13(1):47-56. Doi: 10.5455/PBS.20221101060619
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2023
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
January 15, 2024
Study Registration Dates
First Submitted
March 28, 2023
First Submitted That Met QC Criteria
April 20, 2023
First Posted (Actual)
April 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEMIRACAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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